HIV/AIDSNCT03175250
Translation of Basic Research in Cognitive Science to HIV Risk
A study testing Health Education, Action Plan and Memory Practice in people with HIV/AIDS, run by Claremont Graduate University.
Trial summary
A randomized trial was conducted at drug diversion educational programs with a sample of 343 adult drug offenders who volunteered for the study. The trial tested three different interventions on HIV testing and condom use, with a 3 month follow-up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Health Education, Action Plan and Memory Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2013to 31 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in drug diversion education program
- Minimum age 18
- Understand English
Who cannot join
- Under 18
- Do not understand English
- Obviously intoxicated
About this study
Official title: Action Plans & Memory Consolidation: Reducing HIV Risk in Drug Users
A randomized trial was conducted at drug diversion educational programs with a sample of 343 adult drug offenders who volunteered for the study. The trial tested three different interventions on HIV testing and condom use, with a 3 month follow-up. The study translated consistent basic research showing strong effects of memory practice on memory for new material. One of the conditions involved extensive memory practice of action plans involving HIV testing and condom use. Other conditions varied two active control interventions. Results showed that the memory practice condition led to a substantially larger odds of HIV testing than did the two control conditions. Condom use was also significantly more frequent in the memory practice condition than in one of the control conditions but was not significantly different from the second control condition.
Read the detailed description
This study translated basic research from several areas of cognitive science to a new intervention procedure designed to reduce HIV risk and increase screening for HIV and other infections. A randomized trial was conducted (N = 343) to test effects on testing for infection (HIV and hepatitis B/C) and condom use frequency in a sample of drug offenders at risk for infection. Many populations of drug offenders are not currently receiving evidence-based prevention for HIV or hepatitis and are in need of effective interventions that can be used in existing drug programs. At three-month follow-up, the results revealed that the condition translating basic research on memory practice and integrative processing significantly increased the odds of infection testing as compared to two alternative conditions. This condition also significantly improved the extent of condom use, compared to a traditional health education condition. The results show promise for increased translation of basic research on memory to behavioral interventions on health and prevention science. Such procedures can be effectively applied in a complex field setting in existing drug diversion programs.
- Conditions
- HIV/AIDS
- Being tested
- Health Education, Action Plan, Memory Practice
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
Videos (AIDSvideos.org) were presented on individually-assigned laptops and covered HIV risk, condom use, safe sex, and infection testing
Action PlanBehavioural
Participants selected situations for condom use and screening for HIV and hepatitis on individually-assigned laptops. They linked these situations to preventive behaviors regarding screening and condom use.
Memory PracticeBehavioural
Participants engaged in several different types of memory practice procedures on assigned laptops. The procedures focused on memory for action plans for screening and condom use.
| Study group | Role | What they receive |
|---|---|---|
| Health Education | Active comparator | This condition included live health education followed by health education videos on HIV risks, testing, and condom use. The videos were presented over laptop. Receives: Behavioral: Health Education |
| Action Plan | Active comparator | This condition included live health education followed by computerized procedures focusing on action plans for HIV testing and condom use and some of the same health education videos in the Health Education condition. Receives: Behavioral: Action Plan |
| Memory Practice | Experimental | This condition included live health education followed by computerized action plan procedures (as in the Action Plan condition), followed by several memory practice procedures also delivered over laptop. The memory practice procedures were designed to help participants more readily retrieve and use action plans in critical situations. Receives: Behavioral: Memory Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV and other infection testing
HIV testing was measured with items from the National Sexual Health Survey (Catania et al., 1992). Hepatitis testing items were assessed in an identical structure. Testing for other sexually transmitted diseases was measured with items from the AIDS Risk Behavior Assessment (Donenberg et al., 2001). These items were tabulated to form a binary variable of whether participants reported testing for HIV, hepatitis, or other sexually transmitted diseases within the past 3 months (3 months following intervention).
Measured: Past 3 months
Condom use
Condom use was assessed with three condom use frequency items from the HIV Risk-taking Behavior Scale (Darke et al., 1991; α =.70; test-retest, r = .86). Response agreement between participants and their sex partners ranged from 88% to 100% in previous research. The questions asked how often participants used condoms in the past 3 months (following the intervention) when having vaginal, oral, or anal sex on a 5-point scale: never, some of the time, about half of the time, most of the time, always.
Measured: Past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start15 Oct 2013
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned at the individual level to one of three different conditions within each drug diversion class.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claremont Graduate University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alan Stacy, Claremont Graduate University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175250
- Sponsor's protocol ID
- 1R01DA033871
- Other IDs
- 1R01DA033871
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pretest and outcome data will be made available after publication. Data can be obtained from the PI at alan.stacy@cgu.edu
Publications
Catania JA, Coates TJ, Stall R, Turner H, Peterson J, Hearst N, Dolcini MM, Hudes E, Gagnon J, Wiley J, et al. Prevalence of AIDS-related risk factors and condom use in the United States. Science. 1992 Nov 13;258(5085):1101-6. doi: 10.1126/science.1439818.
PubMed 1439818Donenberg GR, Emerson E, Bryant FB, Wilson H, Weber-Shifrin E. Understanding AIDS-risk behavior among adolescents in psychiatric care: links to psychopathology and peer relationships. J Am Acad Child Adolesc Psychiatry. 2001 Jun;40(6):642-53. doi: 10.1097/00004583-200106000-00008.
PubMed 11392341Darke S, Hall W, Heather N, Ward J, Wodak A. The reliability and validity of a scale to measure HIV risk-taking behaviour among intravenous drug users. AIDS. 1991 Feb;5(2):181-5. doi: 10.1097/00002030-199102000-00008.
PubMed 2031690
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Plans & Memory Consolidation: Reducing HIV Risk in Drug Users
- ClinicalTrials.gov ID
- NCT03175250
- Acronym / sponsor ID
- 1R01DA033871
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Claremont Graduate UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Oct 2013 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized trial was conducted at drug diversion educational programs with a sample of 343 adult drug offenders who volunteered for the study. The trial tested three different interventions on HIV testing and condom use, with a 3 month follow-up. The study translated consistent basic research showing strong effects of memory practice on memory for new material. One of the conditions involved extensive memory practice of action plans involving HIV testing and condom use. Other conditions varied two active control interventions. Results showed that the memory practice condition led to a substantially larger odds of HIV testing than did the two control conditions. Condom use was also significantly more frequent in the memory practice condition than in one of the control conditions but was not significantly different from the second control condition.
Detailed description
This study translated basic research from several areas of cognitive science to a new intervention procedure designed to reduce HIV risk and increase screening for HIV and other infections. A randomized trial was conducted (N = 343) to test effects on testing for infection (HIV and hepatitis B/C) and condom use frequency in a sample of drug offenders at risk for infection. Many populations of drug offenders are not currently receiving evidence-based prevention for HIV or hepatitis and are in need of effective interventions that can be used in existing drug programs. At three-month follow-up, the results revealed that the condition translating basic research on memory practice and integrative processing significantly increased the odds of infection testing as compared to two alternative conditions. This condition also significantly improved the extent of condom use, compared to a traditional health education condition. The results show promise for increased translation of basic research on memory to behavioral interventions on health and prevention science. Such procedures can be effectively applied in a complex field setting in existing drug diversion programs.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned at the individual level to one of three different conditions within each drug diversion class.
| Arm | Type | Receives |
|---|---|---|
| Health Education | Active comparator | Behavioral: Health EducationThis condition included live health education followed by health education videos on HIV risks, testing, and condom use. The videos were presented over laptop. |
| Action Plan | Active comparator | Behavioral: Action PlanThis condition included live health education followed by computerized procedures focusing on action plans for HIV testing and condom use and some of the same health education videos in the Health Education condition. |
| Memory Practice | Experimental | Behavioral: Memory PracticeThis condition included live health education followed by computerized action plan procedures (as in the Action Plan condition), followed by several memory practice procedures also delivered over laptop. The memory practice procedures were designed to help participants more readily retrieve and use action plans in critical situations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled in drug diversion education program
- Minimum age 18
- Understand English
Key exclusion criteria (3 listed)
- Under 18
- Do not understand English
- Obviously intoxicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationVideos (AIDSvideos.org) were presented on individually-assigned laptops and covered HIV risk, condom use, safe sex, and infection testing | Behavioural | Health Education |
| Action PlanParticipants selected situations for condom use and screening for HIV and hepatitis on individually-assigned laptops. They linked these situations to preventive behaviors regarding screening and condom use. | Behavioural | Action Plan |
| Memory PracticeParticipants engaged in several different types of memory practice procedures on assigned laptops. The procedures focused on memory for action plans for screening and condom use. | Behavioural | Memory Practice |
Primary outcome
HIV and other infection testing
Time frame: Past 3 months
HIV testing was measured with items from the National Sexual Health Survey (Catania et al., 1992). Hepatitis testing items were assessed in an identical structure. Testing for other sexually transmitted diseases was measured with items from the AIDS Risk Behavior Assessment (Donenberg et al., 2001). These items were tabulated to form a binary variable of whether participants reported testing for HIV, hepatitis, or other sexually transmitted diseases within the past 3 months (3 months following intervention).
Condom use
Time frame: Past 3 months
Condom use was assessed with three condom use frequency items from the HIV Risk-taking Behavior Scale (Darke et al., 1991; α =.70; test-retest, r = .86). Response agreement between participants and their sex partners ranged from 88% to 100% in previous research. The questions asked how often participants used condoms in the past 3 months (following the intervention) when having vaginal, oral, or anal sex on a 5-point scale: never, some of the time, about half of the time, most of the time, always.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Background: PubMed 1439818Catania JA, Coates TJ, Stall R, Turner H, Peterson J, Hearst N, Dolcini MM, Hudes E, Gagnon J, Wiley J, et al. Prevalence of AIDS-related risk factors and condom use in the United States. Science. 1992 Nov 13;258(5085):1101-6. doi: 10.1126/science.1439818.
- Background: PubMed 11392341Donenberg GR, Emerson E, Bryant FB, Wilson H, Weber-Shifrin E. Understanding AIDS-risk behavior among adolescents in psychiatric care: links to psychopathology and peer relationships. J Am Acad Child Adolesc Psychiatry. 2001 Jun;40(6):642-53. doi: 10.1097/00004583-200106000-00008.
- Background: PubMed 2031690Darke S, Hall W, Heather N, Ward J, Wodak A. The reliability and validity of a scale to measure HIV risk-taking behaviour among intravenous drug users. AIDS. 1991 Feb;5(2):181-5. doi: 10.1097/00002030-199102000-00008.
- website with HIV related videos used in interventionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pretest and outcome data will be made available after publication. Data can be obtained from the PI at alan.stacy@cgu.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education, Action Plan and Memory Practice in people with HIV/AIDS, run by Claremont Graduate University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV and other infection testing (time frame: Past 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175250, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.